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NCT02020889 · ClinicalTrials.gov registry record · Phase 3
A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
NCT02020889: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT02020889 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 136 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02020889, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
Study Summary
The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) receiving standard of care therapy including background corticosteroid therapy with or without immunosuppressive therapy. During the treatment period, in accordance with standard of care, corticosteroid dose will be tapered. The key outcomes in the study focus on evaluation of clinical remission, defined as Birmingham Vasculitis Activity Score (BVAS)=0 with a corticosteroid dose of \<=4 mg/day prednisolone/prednisone, reduction in disease relapse and reduction in corticosteroid requirement.
Primary Outcome
Total accrued duration of remission is the accrued number of weeks where Birmingham Vasculitis Activity Score (BVAS) =0 plus prednisolone/prednisone dose \<=4 mg/day over the 52 week study treatment period was reported. The accrued duration was categorized into zero, \>0 to \<12 weeks, 12 to \<24 weeks, 24 to \<36 weeks and \>=36 weeks. Statistical analysis was based on a proportional odds regression model with covariates including treatment group, Baseline prednisolone/prednisone daily dose, Ba
Interventions
- DRUG Placebo
- BIOLOGICAL Mepolizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2014-02-05 |
| Est. Completion | 2016-09-05 |
| Phase | Phase 3 |
What the finished NCT02020889 record still lists
NCT02020889 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02020889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02020889 about?
NCT02020889 is a clinical study titled "A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis". The purpose of this randomized, double-blind study is to investigate the efficacy and safety of mepolizumab (300 milligram \[mg\] administered subcutaneously \[SC\] every 4 weeks) compared with placebo over a 52-week study treatment period in subjects with relapsing or refractory Eosinophilic Granul...
What is the current status of trial NCT02020889?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2014-02-05. Estimated completion is 2016-09-05.
What interventions are being tested in trial NCT02020889?
The interventions under investigation include: Placebo (DRUG), Mepolizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02020889?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02020889's enrollment target sits among peer trials
136 1580th of 2000 higher than 419 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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